Medicinal mushrooms saw skyrocketing growth in 2020 during the COVID-19 pandemic. Is this the first step in their mainstream journey?

Are medicinal mushrooms on the cusp of mainstream fame?

Stauber Performance Ingredients (Fullerton, CA) and Hawkins launched an all-natural, solvent-free liquid pomegranate extract, Pomma+ Nectar, derived from whole California pomegranates.

“For years, we have had success with our Pomma+ extract, and through further development, we identified the unique attributes of the Pomma+ Nectar,” said Mike Hess, technical director of Hawkins, in a press release. “Our nectar is a flexible food/beverage ingredient which is high in polyphenols and tastes great. I am excited to be part of a team always searching for innovative ingredient solutions for our customers.”

Pomma+ Nectar is loaded with potassium and beneficial pomegranate polyphenols. It functions as a low-calorie flavor enhancer with a low-glycemic value. The functional ingredient allows for creations of products with crisp, tangy, and tart flavors, while intensifying the health benefits attributed to the pomegranate. 

“Pomma+ Nectar offers our functional beverage creators, brewers, and distiller partners across the country the opportunity to produce seltzers, functional non-alcoholic beverages, flavored distilled spirits, and fruit beers,” said Becki Schwietz, product manager and director at Stauber, in a press release. “The unique flavor and functional profile of the Pomma+ Nectar provides a wide range of product development opportunities including smoothies, yogurts, dressings, marinades and frozen treats. Pomma+ Nectar is a brilliant functional flavoring agent and low sugar alternative for a variety of beverage and food product formulations. All of us at Stauber and Hawkins are thrilled to bring this product to our customers.”

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Stauber Performance Ingredients and Hawkins launched an all-natural, solvent-free liquid pomegranate extract, Pomma+ Nectar, derived from whole California pomegranates. 

Stauber, Hawkins launch Pomma+ Nectar pomegranate syrup

As more consumers see the value of incorporating fiber into their diet, and manufacturers realize the utility of fiber ingredients, fiber content claims on finished food and beverage products are bound to continue growing.

Consuming fiber through food and beverages affords a level of convenience absent from traditional dietary supplements, says Rob Brewster, president of Ingredients by Nature (IBN; Montclair, CA). Ease of use, encouraging more likely usage, is important when one considers the lack of fiber consumed in a typical diet. “Most Americans do not get enough fiber in their normal diet, but there is also more awareness of the benefits different fibers can deliver for heart, digestive, and gut health,” Brewster explains.

“The greatest demand for fiber comes primarily from nutritional products, baked foods (including bread, pizza crust, and tortillas), as well as nutritional bars,” says Diana M. Nieto, senior manager, business development, Starch-Based Texturizers U.S./Canada, for Ingredion Inc. (Westchester, IL). For these applications, Nieto recommends resistant starches such as Ingredion’s Novelose 3490, an insoluble fiber derived from tapioca. “Besides the fiber contribution, resistant starches have lower water-holding capacity, allowing formulators to replace wheat while lowering the calories and net carbs and, in certain applications, improving texture.”

For formulating products such as drinkable yogurts, smoothies, and snack bars, Brewster recommends citrus fibers. He says: “Citrus fibers have become more popular over the last couple of years because they improve gelling, thickening, stabilizing, and water-binding capabilities more than other available fibers,” adding that they may also support blood glucose and cardiovascular health in addition to digestive health.

Fiber has also become an important tool for sugar reduction. “Soluble fibers, since they can provide some level of sweetness, provide formulators a way to not only build back texture when reducing sugar but also to help round out the overall sweetness of the formulation,” says Nieto. Ingredion’s Versafibe 285, for example, is a soluble corn fiber that can contribute up to 25% sugar reduction in a wide range of applications.

For its part, Ingredients by Nature supplies a functional fiber called MonkFiber derived from the husks of monk fruit. “The charm of MonkFiber is that in addition to providing a healthy dose of dietary fiber, the ingredient has a sweet profile—100 to 250 [times] sweeter than sugar—and contains zero calories,” says Brewster. “This will help appeal to consumers who do not normally like the taste of their fiber products by improving taste without resorting to sugar.”

As demand grows for fiber-rich products, suppliers also want to be able to capture a wider consumer base by accommodating trends such as low FODMAP. Low FODMAP is particularly complementary because of its association with digestive health. For example, Ingredion’s Novelose 3490 is low-FODMAP certified and an easy addition to snack, bakery, and even pasta applications.

“Low FODMAP is a compelling new way for brands to deliver digestive wellness to their consumers and to capture growth in a health and wellness megatrend that’s here to stay, especially given the global pandemic,” explains Ramesh Thiyagarajan, global strategic senior marketing manager, Starch-Based Texturizers, Ingredion. “From Ingredion research, we’ve learned that mainstream consumers currently have minimal awareness of low FODMAP. However, according to the research, once they hear it supports digestive wellness, they then have high purchase interest in products with the ‘low FODMAP’ claim. ‘Low FODMAP’ becomes an immediate shorthand to support an overall digestive wellness. Manufacturers, with minimal investment in educating the consumer, can drive scalable and profitable growth in digestive wellness.”

With their digestive health benefits, certain fibers can also branch off into the burgeoning prebiotic space. “Globally, we are seeing some indication that manufacturers are directionally shifting efforts toward prebiotics. This shift is evidenced by the growth in launches with prebiotic claims since 2018,” says Carolyn Phillips, market insights manager, Ingredion. “Although [new product launches] with fiber claims still overwhelmingly outweigh prebiotic introductions, the former shows a flat growth rate.”

“Prebiotics have a lot of potential, especially as more research is developed. But in association with that research, there needs to be more consumer education about what prebiotics are and do,” adds Brewster.

Success in the nutrition bar space requires consistent quality and continued innovation, including with fiber.

Fiber competition in the nutrition bar category

The U.S. Department of Agriculture (USDA) has published its 

, establishing the U.S. Domestic Hemp Production Program, on October 31, 2019, and opened a 60-day public comment period that was extended until January 29, 2020. Based on comments submitted during this period, USDA made a number of changes that now appear in the final rule. 

When it comes to exceeding acceptable THC levels, called negligent violation, the final rule raises the negligence threshold from 0.5% to 1%, but limits the maximum number of negligent violations that a producer can receive in a calendar year to one. For the disposal of non-compliant, the final rule does not require using a DEA reverse distributor or law enforcements, instead expanding to disposal and remediation measures available to producers. Acceptable remediation techniques will be provided by the Agricultural Marketing Service in a separate guidance document. 

Because of the insufficient number of DEA-registered laboratories, DEA has agreed extend the enforcement flexibility to allow non-DEA registered labs to test hemp until January 1, 2021. In the meantime, DEA is processing lab registration applications quickly to get more hemp testing labs to be DEA-registered. The final rule has also extended the time window for the collection of samples before harvest from 15 days to 30 days.

During the comment period stakeholders requested that they be able to take samples from a greater part of the hemp plant or the entire plant, as well as from a smaller number of plants. The final rule, therefore, allows states and tribes to adopt a performance-based approach to sampling in their plans, but plans must be submitted to USDA for approval. Additionally, the final rule addresses the extent of tribal regulatory authority and provides that a tribe may exercise jurisdiction and therefore regulatory authority over the production of hemp throughout its territory. Essentially, the final rule does not distinguish between States and Native American Tribes, giving them equal ability to authorize and regulate the production of hemp within their jurisdiction.

“With the publication of this final rule, USDA brings to a close a full and transparent rule-making process that started with a hemp listening session in March 2019,” said USDA marketing and regulatory programs under secretary Greg Ibach, in a press release. “USDA staff have taken the information you have provided through three comment periods and from your experiences over a growing season to develop regulations that meet Congressional intent while providing a fair, consistent, science-based process for states, tribes and individual producers. USDA staff will continue to conduct education and outreach to help industry achieve compliance with the requirements.”

Following an extended comment period, USDA made a number of revisions to rules regarding the testing, disposal, and regulation of hemp. 

USDA publishes final rule for the Domestic Hemp Production Program

BGG World (Irvine, CA) was issued a patent from the United States Patent and Trademark Office for the use of astaxanthin to support heart function during exercise (US Patent #10,827,775).

The patent is based on results from a clinical trial, sponsored by BGG, with amateur athletes preparing for a half marathon. Subjects supplementing BGG’s AstaZine natural astaxanthin experienced heart rates on average 10% lower during endurance training than the placebo group. 

According to Shawn Talbott, lead researcher of the study, “Subjects were able to perform the same amount of ‘work’ but at lower cardiovascular ‘strain’ after supplementing with astaxanthin.”

Further, lead inventor of the patent and BGG’s global chief scientific officer, Yanmei Li, PhD, said in a press release, “BGG focuses on innovation by dedicating 5% of gross revenue to R&D. As a prime example of this policy, we are one of only a very small handful of astaxanthin producers sponsoring clinical research to validate our product and have published several astaxanthin clinical studies over the last few years. This patent is another example of how BGG supports our customers through our investment in research and constant innovation; we’ve successfully opened up a whole new area of health benefits for our astaxanthin customers to focus on.”

BGG World was issued a patent from the United States Patent and Trademark Office for the use of astaxanthin to support heart function during exercise (US Patent #10,827,775).   

BGG issued patent on AstaZine natural astaxanthin for heart health

Body&Fit, Glanbia Performance Nutrition’s direct-to-consumer brand, and Lonza are collaborating to expand Body&Fit’s nutrition, supplements and dietary solutions utilizing Lonza’s Duocap capsule portfolio and specialty nutrition ingredients. 

“This collaboration with Body&Fit is a perfect showcase of our combined expertise in providing high-quality sports nutrition and dietary supplements in unique dose-delivery formats,” said Roel van de Put, business development manager for Lonza, in a press release. “We are excited to work with Body&Fit to help consumers live a fitter and healthier lifestyle with new and innovative nutrition products.”

With a capsule-in-a-capsule design, Lonza’s Duocap technology offers combined dosing of incompatible ingredients. The first two Body&Fit product utilizing Duocap technology are Beauty Skin Duo and Pro B Duo. As a way to tap into clean label trends, the products are launching using a titanium dioxide (TiO2)-free inner capsule.

“Body&Fit, just like Lonza, is constantly looking for unique solutions to bring truly innovative products to the market,” said Szabina Pál, product development manager for the tablet and capsule portfolio at Body&Fit, in a press release. “Lonza’s cutting-edge technologies, premium ingredients, and forward-thinking concepts are the perfect fit with our vision, mission, and business model. We are very excited to combine our strengths to maximize our potential.” 

Body&Fit has plans to launch three additional products for immune health, sleep, and mood and anxiety in early 2021, all featuring Lonza’s Duocap capsule technology, and a joint health and support supplement, utilizing Lonza’s TiO2-free hard capsules portfolio and its patented UC-II undenatured type II collagen ingredient. 

The two companies are also collaborating on the exclusive development of an intra-workout product featuring MuscleGuard formulation from Lonza, a unique blend that delivers pre-, intra- and post-workout support.

Body&Fit, Glanbia Performance Nutrition’s direct-to-consumer brand, and Lonza are collaborating to expand Body&Fit’s nutrition, supplements and dietary solutions utilizing Lonza’s Duocap capsule portfolio and specialty nutrition ingredients.

Lonza, Body&Fit collaborate on specialty supplements using Duocap capsule technology

The New York State Department of Health (NYSDH) recently proposed new 

which establishes requirements for licensure for extraction and manufacturing, as well as the sale of hemp-derived cannabidiol (CBD) products. As it did with proposed legislation in 

, the Council for Responsible Nutrition (CRN; Washington, D.C.) has issued 

 to the NYSDH, proposing revisions to the language that are more consistent with federal law, and prevents a patchwork of state laws.

Among the revisions suggested by CRN are more detailed definitions that offer clarity and are consistent with the 2018 Farm Bill. For example, CRN asks that the NYSDH, in line with the 2018 Farm Bill, define hemp-derived CBD as containing no more than 0.3% THC by dry weight. NYSDH fails to make this distinction throughout its proposed regulation. In its definition of “Broad spectrum,” NYSHD writes: “Broad spectrum means a concentrate extracted from hemp containing multiple cannabinoids, but where all Δ9-Tetrahydrocannabinol (THC) has been removed.”

CRN asks that the definition be revised to: “Broad spectrum means an extract from hemp containing multiple cannabinoids, but where all Δ9-Tetrahydrocannabinol (THC) has been removed to non-detectable levels to be in compliance with the United States Department of Agriculture 0.3% THC limit for raw flower and finished products.”

Similarly, NYSDH defined “hemp extract” to mean “all derivatives, extracts, cannabinoids, isomers, acids, salts of isomers derived from hemp and used for human consumption, with a Δ9-Tetrahydrocannabinol concentration of not more than an amount determined by the department.”

Again, CRN asks that NYSDH include the 0.3% THC threshold with the following revision: “Hemp extract means any derivative, extract, cannabinoid, isomer, acid, salt of isomer derived from hemp and used for human consumption, with a Δ9-Tetrahydrocannabinol. concentration of not more than an amount determined by the department, provided the amount is not less than 0.3% on a dry weight basis.”

The rationale for this inclusion is that the threshold of 0.3% is set by the 2018 Farm Bill and consistent with federal law, and prevents the state from setting a lower threshold which would create a burdensome patchwork of regulations. This is important because as more states issue their own regulation to make up for a lack of federal regulation, it would hurt industry if manufacturers and extractors had to meet different requirements throughout the nation. This would be expensive for business owners, and would create less choice for consumers as brand owners avoid commerce with certain jurisdictions.

CRN hopes that states deviate as little as possible from the federal frameworks established in the 2018 Farm Bill, the Dietary Supplement Health and Education Act of 1994 as well as the Federal Food, Drug & Cosmetic Act so that there is a seamless transition to inevitable federal regulation. CRN hopes this will be accomplished through legislation, specifically, 

H.R. 8179, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020

As it advocates for this important piece of legislation and more consistent regulation between states, CRN has recently expressed frustration with the U.S. Food and Drug Administration (FDA) for a complete lack of progress in developing a regulatory pathway for hemp-derived CBD. For example, a recent 

 issued by the Agency expressed a need for better data, so that they may better understand the use and safety of CBD products. CRN argues that FDA’s quest for information on these products does not have to preclude federal regulation in the meantime.

“[The notice] tries to excuse the agency’s inaction by decrying a lack of data — even as FDA has blocked the New Dietary Ingredient (NDI) route for CBD supplements by declining to review them, and done little that might incentivize data to be presented or invested in research of its own,” says Steve Mister, president and CEO of CRN, in a statement. “But more troubling is that FDA’s essay on data quality misses the point entirely – and fundamentally misunderstands how DSHEA works. As a botanical, under DSHEA, the presumption in the law actually runs the other way. Put plainly, consumers should have access to CBD dietary supplement products absent some reason shown why they should not. FDA could fix this problem today by exercising authority it is clearly given in the law, and immediately enforcing the full array of FDA dietary supplement regulations on the CBD dietary supplement industry.”

The New York State Department of Health recently proposed new cannabinoid hemp regulation which establishes requirements for licensure for extraction and manufacturing, as well as the sale of hemp-derived cannabidiol (CBD) products. 

NY State Department of Health proposes new hemp-derived CBD regulation, CRN responds

COVID-19 has taught us so much already, such as: 1) handwashing really does work, 2) masks save lives, and 3) it doesn’t hurt to keep more toilet paper on hand than you think you’ll actually need.

But one of the lessons that’s stuck most with the health-and-wellness community isn’t just the fact that health is inextricably related to nutrition, but that the way we “do” healthcare in the United States quite simply doesn’t work.

That’s certainly the lesson that Paul Schulick, founder and CEO, For The Biome (Dummerston, VT), takes from all this. “People are looking for immune support and preventative measures beyond social distancing and future vaccines,” he points out, “but our conventional healthcare system is only offering band-aid solutions, for the most part.”

No wonder, then, that the public’s growing skeptical of it. And no wonder that they’re also adopting what Schulick considers “the natural response”—namely, “looking to ‘alternative’ wellness practices.”

Topping that list of alternatives are functional mushrooms, which were attracting attention even before COVID gave a new shine to their relevance. And while mushrooms haven’t fully hit the mainstream yet, Schulick believes, “The more people react to our antiquated and ineffective healthcare system, the more the health benefits of mushrooms will resonate.”

Mushrooms began resonating with health-minded consumers several years ago, according to Jacob Knepper, data product manager, SPINS LLC (Chicago), “when they jumped to prominence as a key part of the adaptogenic movement centered on physical and mental stress management.”

Once shoppers wrapped their heads around the functional fungi’s basics, he continues, they started catching on to mushrooms’ “more holistic benefits,” including blood-sugar and immunity support. By the time the pandemic hit, “mushrooms were already on a steep upward trajectory in both food and beverage applications, and in vitamins and supplements.”

Concerns surrounding COVID-19 have since steepened that trajectory, and mushrooms are now “being catapulted into the spotlight and are likely seeing accelerated growth patterns and product innovation compared to what we may have otherwise seen,” Knepper concludes.

To quantify those observations, he cites SPINS data showing that for the 52 weeks ending October 4, 2020, growth in functional mushroom ingredients was up 49.9% across the board.

“The data suggest that more shoppers are turning to mushrooms in the form of supplements, as these products have grown 63.5% to $30,857,134 over the same time period,” Knepper notes. And zeroing in on the all-important early-COVID stockpiling days, he says the numbers there reflect “a huge spike for these products” during March 2020, when sales reached $5,940,387 over the four weeks to March 22—a 152% increase compared to the same period the previous year.

In retrospect, any observer of the pandemic’s cultural effects could have seen those sales coming, given how handily mushrooms’ functions fit our anxious moment.

After all, as Susan E. Hirsch, formulation manager, Gaia Herbs (Brevard, NC), points out, “People are concerned about their health, the health of their family and friends, and adaptations to new ways of living and working—in some cases managing homeschooling on top of everything else. People have also reported trouble staying focused with all the new distractions they’re dealing with. This new reality has dramatically increased levels of ongoing stress and anxiousness, and these conditions can easily lead to other issues, including sleep and digestive challenges.”

And immunity challenges. “People are becoming more aware of chronic stress’s impact on the immune system,” notes Schulick. “It’s like turbulence for your immune response and accelerates its deficiency and deterioration. You’re much more vulnerable to infection when chronic stress goes unchecked.”

Which is where mushrooms come in. Not only are they safe to take on a daily basis, Schulick says; they’re packed with protective terpenoids and beta-glucans that “‘train’ and rehabilitate the immune system, modulating pro- and anti-inflammatory cytokines to help support what we call ‘a wiser immune system’ that responds more precisely while helping the body adapt to stress,” he explains.

Scientists are fast at work figuring out why. “Virtually every day,” Schulick says, “more research is being published on mushrooms, focusing on their ability to help alleviate human suffering.”

Brien Quirk, director of R&D, Draco Natural Products (San Jose, CA), notes that a number of current studies examine mushrooms’ antiviral properties against influenza, which he says “is even more of a concern while we’re dealing with COVID.” To understand how mushrooms effect their antiviral benefits, it helps to understand the pathways whereby flu viruses make us sick in the first place.

One such pathway involves the glycoprotein hemagglutinin (H), a large sugar-binding lectin that sits outside viral particles and helps bind them to new host cells. Another involves the enzyme neuraminidase (N), which eases viral particles’ transit through the respiratory tract mucus membrane and helps release “flu-virus offspring” from infected cells “so that they can disseminate to infect other cells,” as Quirk explains. (When we see seasonal flus named with HN numbers, like H1N1, those numbers reference the particular strain of hemagglutinin and neuraminidase involved.)

So where do mushrooms come in? Aside from their general immune-boosting properties, they help block these two pathways. In fact, Quirk says, “Many immune-support medicinal mushrooms have been found to inhibit the neuraminidase pathway, which is the same mechanism Tamiflu uses.”

For example, reishi, maitake, shiitake, cordyceps, and 

 all display this capacity, with a recent study on reishi (genus 

) finding inhibitory effects for two of its triterpenoids—ganoderic acid T-Q and TR—against neuraminidases in the H5N1 and H1N1 virus strains.

Another study involving influenza virus type A (serotype H1N1) found that oyster mushroom, enokitake, and turkey tail all provided effective inhibition against the pathway, as well.

 “Turkey tail was even noted to have a high therapeutic index and was suggested as a promising new antiviral agent against some flu strains,” Quirk adds.

And while conceding that none of these fungi will likely prevent the flu or its more serious complications, Quirk believes that “they may be able to help the body improve its defense based on a combination of their immune support and other bioactive effects.”

Whether consumers are familiar with the research or not, their demand for mushrooms is strong enough for Quirk and others to notice. For example, reishi “is almost always the top request,” he says, with lion’s mane—which, like reishi, has purported cognitive, mood, and immune benefits—coming in a close second. “Others we frequently see requested are chaga, 

Jonathan Fitzpatrick, product manager at Gaia Herbs, notes that 

was scoring a search-popularity ranking close to 100 in Google Trends this past autumn, “which means that the term is receiving the highest active search interest level possible.”

And Schulick says that his company has its eye on chaga. “It’s been used for centuries in TCM”—Traditional Chinese Medicine—he notes, “and is known as the ‘king of medicinal mushrooms’ for good reason.”

Case in point: Recent research apparently shows that chaga can inhibit RNA and DNA viruses 

. “The antiviral and anti-inflammatory benefits are quite remarkable,” Schulick says. “In fact, a research paper released this past August focused on the virome-modulating and anti-inflammatory effects of mushrooms and herbs on SARS-CoV-2 infection and stated that ‘one of the potential candidates against the SARS-CoV-2 virus may be 

 The study went on to highlight chaga’s ‘powerful enzymatic system and strong system of defense,’ which has been shown to inhibit pro-inflammatory cytokines associated with COVID-19 and help prevent a ‘cytokine storm’ from overwhelming the immune system.”

Worth noting, Schulick adds, is that these benefits manifest most strongly in high-grade, quality chaga grown specifically on birch trees. “This is because chaga extracts betulinic acid from the birch tree, a key immune-modulating compound and signaling molecule that helps support the resilience of the immune system,” he says. And not surprisingly, this is the chaga his company includes in two of its new immune products.

Similarly, Fitzpatrick notes that another trend in the mushroom space is a preference for extracts from the fruiting-body—the above-ground portion of the fungi that we can see—over those from the underground mycelia network grown on grain. Here, too, Gaia Herbs uses only fruiting-body extracts, as these “contain the most active beneficial constituents”—in particular, the beta-glucans that research associates with immune health and overall wellness, Fitzpatrick says.

Sevanti Mehta, president, Unibar Corp. (Houston), is also excited about mushroom beta-glucans and notes that the company’s Maitake Pt78 mushroom ingredient “delivers a unique and powerful source of immune support by providing the body with essential beta-glucans,” he says. “At a time when everyone has immune health on the mind and when interest in medicinal mushrooms has grown, it was clear that we needed to launch this clinically studied maitake extract to provide an option that can deliver optimal support to the immune system and promote enhanced cellular function.”

Consumers are finding ingredients like Maitake Pt78 and others in products across the board: foods, supplements, beverage mixes—even cosmetics.

To help formulate the latter, Quirk notes that Draco supplies the BioReishi brand of reishi extract, which is standardized to beta-glucans and has moisturizing, anti-inflammatory, and purported skin-healing benefits.

Adds Schulick of For The Biome, “Four of our seven skincare products contain mushrooms as a key ingredient. And as I mentioned, chaga will be featured in two of our upcoming immune formulas set to launch this December,” the month this article was written.

Gaia’s Hirsch is bullish on the potential of mushroom-herb blends, which she credits for helping to “push mushrooms into the spotlight.” Within Gaia’s line of such blends, “my personal go-to and one of my favorite products is our Immune Shine Mushroom & Herbs powder,” she says, which combines adaptogenic mushrooms like maitake and chaga with elderberry, ginger, and astragalus. “I use it in my daily morning routine, as it helps me stay healthy and supports my immune health.”

At SPINS, Knepper’s seen “major increases” for mushrooms in the food supplements category, where mushroom wellness shots and powders generated growth of more than 400% relative to the previous year for the 52 weeks ending October 4, 2020.

Outside of supplements, functional mushrooms gained traction in food and beverages, with the emphasis on beverages and especially beverage mixes. “This segment has grown to about $12 million, with a very healthy growth rate of 22%,” Knepper notes. “Shelf-stable coffee beans, grounds, and instant mixes are definitely a hot category within the segment, too, where functional mushrooms products are up 43% compared to the previous 52 weeks.”

Even snack and indulgent categories are seeing mushroom action—ice cream, chips, jerky. “Thanks to a favorable taste and texture profile to go along with their holistic wellness benefits,” Knepper says, “functional mushrooms should continue to see an increased presence across a number of food categories as a highlighted functional ingredient.”

And experts agree, a presence in the food space is the ticket that any mushroom needs to officially go mainstream.

As Quirk says, “When we start seeing more instant-food-based medicinal mushrooms in grocery stores—much as we now see products with goji berries, stevia, and monkfruit—we’ll know that it’s gone full mainstream.”

Fitzpatrick looks forward to mushrooms’ colonization of platforms ranging from gummies and chewables to effervescents, syrups, herbal shots, and even infused lollipops. “It’ll be exciting to see all the ways that mushrooms will be introduced in new and approachable formats,” he says.

But Schulick is holding off on declaring mainstream certification just yet. “From my perspective, mushrooms aren’t even close to being fairly mainstream,” he says. “Their popularity in America is nothing like in Asia or even some European countries when it comes to appreciation and understanding of what they have to offer. I look at the future of mushrooms using the practice of acupuncture as an analogy: If we touch the right points with just the right people, their popularity could go viral overnight. Pun intended.”

And now could be the right time for that to happen. “If we don’t make major modifications to our lifestyles, the viral upheaval that SARS-CoV-2 caused will be just the tip of the iceberg,” Schulick predicts. “To overcome what’s ahead, people will need to remain proactive regarding holistic wellness. In conclusion, all pointers suggest that mushrooms will continue to mushroom.”

Zhu Q et al. “Inhibition of neuraminidase by 

 triterpenoids and implications for neuraminidase inhibitor design.” 

Krupodorova T et al. “Antiviral activity of 

 mycelia against influenza type A (serotype H1N1) and herpes simplex virus type 2 in cell culture.” 

Shahzad F et al. “The antiviral, anti-inflammatory effects of natural medicinal herbs and mushrooms and SARS-CoV-2 infection.” 

The Ninth Circuit Court of Appeals upheld a previous decision of the U.S. District Court of the Northern District of California in favor of the defendants: Target Corporation, International Vitamin Corporation, and Perrigo Company of Southern California Inc. The plaintiff challenged the labeling of the dietary supplement biotin, which stated that the supplement “helps support healthy hair and skin.” The Ninth Circuit Court of Appeals ruled that the plaintiff’s state law claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), which under 21 U.S.C. § 343(r)(6)(B) authorizes statements such as disease claims and structure/function claims. In the case of the biotic product, the court ruled that the challenged claim met the criteria for a permissible structure/function claim.

“The defendants met the first requirement for its structure/function claim because it had substantiation that biotin ‘helps support healthy hair and skin,’ and that statement was truthful and not misleading. Manufacturers may make structure/function claims about a nutrients’ general role on the human body without disclosing whether the product will provide a health benefit to each consumer,” stated the 

. “Second, the biotin product label had the appropriate disclosures. Third, the biotin product label did not claim to treat diseases. Because the structure/function claim about biotin met the FDCA’s requirements, plaintiff’s state law claims amounted to an imposition of different standards from the FDCA.”

The Council for Responsible Nutrition (CRN; Washington, D.C.) praised the decision, which protects both industry and consumers by maintaining the federal framework. “We applaud this decision as it protects both industry and consumers by maintaining the federal framework, allowing dietary supplement manufacturers to disseminate information about how nutrients affect the health and function of the body and empowering consumers to make informed choices about nutrition,” said Megan Olsen, vice president and associate general counsel for CRN, in a statement. “CRN submitted an 

 in support of product claims surrounding biotin in April 2020. CRN recognizes the importance of filing these amicus briefs on behalf of industry to protect the federal standards that are in place and prevent private actors from overhauling this carefully crafted framework and creating a patchwork of conflicting substantiation standards inconsistent with the federal system.”

The Ninth Circuit Court of Appeals upholds ruling that federal dietary supplement framework preempts state law in case against biotin claims.

Court of Appeals upholds ruling that federal dietary supplement framework preempts state law

The Natural Products Association (NPA; Washington, D.C.) has sent a letter to governors from all 50 states urging them to declare health food stores essential. This would ensure that millions of Americans continue to have access to dietary supplements to support their health, and ensure access to vaccines for those working at natural health stores as front-line workers.

“There is uncertainty right now created by individual interpretations on whether health and nutrition stores have been deemed essential retail establishments,” said Daniel Fabricant, president and CEO of NPA, in his 

. “For the millions of people who rely on stores that retail dietary supplements this uncertainty is troubling and could cause such stores to close unnecessarily, and not allow their front-line workers to have access to vaccination per schedule 1C of the COVID-19 vaccination disbursement.”

Dietary supplement manufacturers are referred to as essential in the latest CISA guidance (version 4.0), says Fabricant in his letter, therefore it would be consistent with existing policy to classify health food stores as essential, and therefore the whole supply chain would have access to vaccination.

“I believe that this issue could be simply resolved if the interpretation on retail storefronts by all local jurisdictions was coordinated with the federal guidelines thus putting all health and nutrition stores on par with grocery and drug stores as essential businesses,” explains Fabricant in his letter. “The majority of states (47) deemed all health and nutrition stores on par with grocery and drug stores as essential businesses during the spring of 2020, thus the vaccination scheduling of these essential workers would also be consistent with precedent.”

The Natural Products Association has sent a letter to governors from all 50 states urging them to declare health food stores essential. 

NPA urges governors of all 50 states to declare health food store essential

TA Associates (Mumbai, India), a global growth private equity firm, acquired a significant stake in OmniActive Health Technologies (Morristown, NJ). Sanjaya Mariwala, founder and executive chairman of OmniActive, has also increased his personal holding. Financial terms of the transaction were not disclosed.

“We are pleased to welcome TA Associates as a strategic investor and partner for the next phase of OmniActive’s growth journey,” Mariwala said in a press release. “We believe that TA has deep capabilities and experience investing in companies focused on nutritional ingredients, and shares OmniActive’s vision of bringing innovative, natural and science‐based solutions to our customers and end consumers. We intend to leverage our strong management capabilities and TA’s distinctive M&A sourcing engine to drive programmatic M&A and in‐licensing to continuously deliver innovation to our customers.”

“We believe that the nutritional ingredients space will see strong growth over the next decade,” said Naresh Patwari, a director at TA Associates Advisory Private Limited, in a press release. “OmniActive has built a strong reputation and deep customer relationships by focusing on natural, R&D-led innovative ingredients. We look forward to working together with Mariwala and the OmniActive management team to further accelerate the growth in this business through organic levers and M&A.”

“We believe that TA’s global healthcare experience will be valuable in supporting OmniActive’s next phase of growth through continued organic growth and strategic acquisitions,” added Jim Hamilton, CEO of OmniActive. “OmniActive has been growing at an accelerated pace, driven by a portfolio of branded, innovative natural products with clinically supported health benefits, and we are excited to continue this growth journey and supporting our customers with TA as our new equity partner.”

TA Associates, a global growth private equity firm, acquired a significant stake in OmniActive Health Technologies. Sanjaya Mariwala, founder and executive chairman of OmniActive, has also increased his personal holding.

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